Penfield Search Partners
Contact: Barbara Day 201.784.9028 firstname.lastname@example.org
The company is a global biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join them and make a difference. They hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration, and personal development. Through a culture of inclusion, they create a better, more productive work environment. They believe that the diverse experiences and perspectives of all their employees help to drive innovation and transformative business results.
The Biostatistician, Translational Medicine will serve as statistical partner with Translational Sciences, Biomarkers and Precision Medicine to discover and develop biomarkers to diagnostics for use with therapeutic products and enhance precision medicine at the company.
- Provides strategic, scientific, and statistical expertise as a core member of Translational Medicine Teams.
- Provides statistical expertise and guidance on the scientific and statistical strategy and execution of the strategy for the development of candidate predictive biomarker(s) and precision medicine.
- Partners with Biomarkers Leads and Translational Sciences groups to develop and optimize biomarker assays, assess and optimize biomarker technology platforms, including technology platform due diligence.
- Partners with Biomarkers and Precision Medicine in discovering potential pharmacodiagnostic biomarkers to provide statistical expertise and rigor in the design of studies, statistical analysis and inferences, including control for multiplicity and mitigation for overfitting when applicable to biomarker signature efforts.
- Partners with leads and protocol statisticians in reviewing protocols and statistical analysis plans and providing biomarker/diagnostic expertise and guidance during plan development.
- Scientific and strategic input into pre-Investigational Device Exemption and HA documents and therapeutic program milestone presentations containing pharmacodiagnostic plans.
- Providing scientific and strategic input during development and execution phase of diagnostic registration and regulatory reviews, including interactions with diagnostic partner companies and Health Authorities.
- Contributes to the evolving pharmacodiagnostics and precision medicine statistical landscape internally and externally by providing education internally and attending and presenting at workshops and meetings and sharing the learnings.
- Ph.D. or equivalent in statistics or related field.
- 7+ years of clinical, pharmacodiagnostics, biomarkers discovery and development, regulatory interactions, filing support experience.
- Biostatistician, Translational Medicine, Global Biometric Sciences. Expert knowledge of the precision medicine literature and statistical approaches to discovering, developing and validating companion diagnostics and biomarkers, including regulatory requirements.
- Strong technical skills, including but not limited to general linear and mixed models, survival analysis, high-dimensional data analysis, bayesian statistics, design of experiments, statistical methods for biomarker assay development and validation and joint evaluation of therapies for efficacy and safety with biomarkers for prediction and classification.
- Excellent verbal and written communications skills.
- Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.
- This position may require up to 20% domestic and/or international business travel.
The company recognizes the importance of balance and flexibility in our work environment. They offer a wide variety of competitive benefits, services and programs that provide their employees the resources to pursue their goals, both at work and in their personal lives.